Newborn whole-genome sequencing and genetic disease risk in pregnancy and early life
Official title: Accurate Assessment and Intervention Research on Newborn Whole Genome Sequencing and Genetic Disease Risk(China Baby Omics)
Run by Women's Hospital School Of Medicine Zhejiang University · NCT07365254 · Data updated 2026-11-12
This project will collect small biological samples from pregnant families and newborns to try whole-genome sequencing and other multi-omics tests to find genetic disease risks.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1000000 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 14, 2025 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07365254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are families with ongoing pregnancies (natural or assisted conception) or newborn infants who are willing to provide consent, complete questionnaires, and give small biological samples at the participating hospital.
✕Probably not a fit
People who are not pregnant, do not have a newborn, are unwilling to consent or provide samples, or who need immediate therapeutic treatment are unlikely to benefit directly from this observational project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll families during pregnancy or with newborn infants, obtain informed consent, and collect questionnaires and small biological samples at specified times. Samples may include peripheral blood, urine, and vaginal secretions and will undergo multi-omics processing such as nucleic acid extraction, sequencing, proteomics, metabolomics, and microbiome analysis. Generated genomic and other omics data will be stored in the hospital database and made available to approved investigators under review procedures. The project is an observational cohort designed to link genetic, environmental, and clinical data to maternal and child health outcomes.
Why it matters
Potential benefit: If successful, this could enable earlier identification of genetic risks in newborns and inform follow-up monitoring or early interventions.
How similar studies have gone: Similar cohort and newborn genomic sequencing projects internationally have demonstrated feasibility and diagnostic yield for some conditions, but large-scale clinical impact and implementation pathways are still being established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Families with ongoing pregnancies (via assisted reproductive therap or natural conception) and newborn infants. Exclusion Criteria: * None
Where it's running
-
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Hengchao Ruan, phD
- Email: ruanhengchao@zju.edu.cn
- Phone: 0571-88208964
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.